Sensor-controlled digital game for heart failure self-management behavior adherence: A randomized controlled trial

用于心力衰竭自我管理行为依从性的传感器控制数字游戏：一项随机对照试验

• 批准号: 10544503
• 负责人: Kavita Radhakrishnan
• 金额: $ 73.62万
• 依托单位: UNIVERSITY OF TEXAS AT AUSTIN
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-29 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10544503
• 关键词: Accelerometer; Active Learning; Address; Adherence; Adult; Age; Behavior; Behavior Therapy; Behavioral; Behavioral Model; Biometry; Cardiac health; Cellular Phone; Chronic Disease; Clinical Trials; Cognitive; Control Groups; Data; Diabetes Mellitus; Diagnosis; Disparity; Ecological momentary assessment; Education; Educational Materials; Elderly; Electronics; Equilibrium; Face; Feasibility Studies; Feedback; Foundations; Geographic Locations; Geography; Goals; Habits; Health; Health Promotion; Healthcare; Heart; Heart failure; Home; Hospitalization; Incentives; Individual; Intervention; Knowledge; Knowledge Management; Life Style; Measures; Methods; Monitor; Moods; Morbidity - disease rate; Motivation; Oklahoma; Outcome; Participant; Pattern; Pharmaceutical Preparations; Phenotype; Physical activity; Play; Precision Health; Prevention; Psychology; Quality of life; Randomized; Randomized Controlled Clinical Trials; Randomized, Controlled Trials; Recommendation; Regimen; Resources; Rewards; Sampling; Self Efficacy; Self Management; Software Engineering; Standardization; Symptoms; Technology; Texas; Time; Vulnerable Populations; Weight; Weight maintenance regimen; Writing; age group; aged; behavior change; behavioral adherence; behavioral outcome; care burden; compliance behavior; cost; design; digital; effective intervention; efficacy evaluation; evidence base; feasibility trial; functional status; group intervention; health disparity; hospital readmission; impaired functional status; improved; individual response; innovation; insight; mortality; pandemic disease; patient engagement; portability; primary outcome; processing speed; prospective; racial health disparity; recruit; remote intervention; response; satisfaction; scale up; secondary outcome; sensor; skills; social; tool

PROJECT SUMMARY/ABSTRACT Heart failure (HF) is a growing pandemic; in the U.S., the number of those diagnosed with HF is expected to rise to 8 million with annual costs at $69 billion by 2030. Despite effective interventions to reduce HF morbidity and mortality, vulnerable populations with HF suffer disproportionately from hospitalization and mortality especially in the southern U.S. states. Self-management (SM) behavioral interventions to improve HF outcomes are therefore imperative. Remote interventions to promote SM behaviors present an important strategy to address the widening geographical and racial health disparities in HF outcomes. One promising approach is the use of sensor-controlled digital games (SCDGs), which offer affordable, portable, scalable tools to facilitate engagement in HF SM behaviors that show the poorest adherence (weight monitoring and physical activity) while being enjoyable and easy to use. The primary goal of this study is to evaluate the efficacy of a SCDG intervention that integrates HF participants’ behavioral data from weight scale and activity tracker sensors to activate game progress, rewards, and feedback. For Aim 1, we will refine an SCDG that we have already developed for mobile smartphones to be playable for longer durations for sustained behavior adherence to weight-monitoring and physical activity. For Aim 2, using a randomized controlled clinical trial, we will compare the SCDG intervention versus a sensor-only intervention for the primary outcome of rate of engagement in the HF SM behavior of weight-monitoring and the secondary outcomes of physical activity behavior engagement, HF SM knowledge, self-efficacy, HF functional status, hospitalization, and quality of life at baseline and at 6, 12, and 24 weeks. For our sample, we will recruit adults aged 45 years or older from 7 southern U.S. states and hospitalized with HF within the past 6 months. We will randomize 200 participants to either the SCDG intervention group, in which participants will receive sensors that track weight monitoring and activity and will play the SCDG on a mobile smartphone, or a control group that will receive sensors, an app that tracks activity and weight monitoring, and standardized written HF educational materials. For Aim 3, we will conduct a mixed-methods assessment to discern facilitators and barriers impacting participants’ engagement with the sensor-based interventions for HF SM behavior adherence. For Aim 4, based on daily HF SM weight-monitoring and physical activity behavior data and ecological momentary assessments of symptoms, mood, satisfaction, and cognitive status, we will conduct digital phenotyping of HF SM weight- monitoring and physical activity behaviors. This project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF SM behaviors and improve health outcomes among individuals with HF.

项目总结/摘要 心力衰竭（HF）是一种日益严重的流行病;在美国，预计被诊断为HF的人数将 到2030年将增加到800万，每年的成本为690亿美元。尽管采取了有效的干预措施来降低HF发病率 和死亡率，HF弱势人群的住院率和死亡率不成比例 尤其是在美国南部各州。自我管理（SM）行为干预改善HF 因此，必须取得成果。促进SM行为的远程干预是一个重要的 该战略旨在解决HF结局中不断扩大的地理和种族健康差异。一个有希望 一种方法是使用传感器控制的数字游戏（SCDG），它提供了负担得起的，便携式的，可扩展的工具 促进参与HF SM行为，这些行为显示出最差的依从性（体重监测和身体检查）， 活动），同时是愉快和易于使用。本研究的主要目的是评估 整合来自体重秤和活动跟踪器的HF参与者行为数据的SCDG干预 传感器来激活游戏进度、奖励和反馈。对于目标1，我们将完善我们拥有的SCDG 已经为移动的智能手机开发，可播放更长的持续时间，以保持行为 坚持体重监测和身体活动。对于目标2，使用随机对照临床试验，我们 将比较SCDG干预与仅探头干预的主要结局， 参与体重监测的HF SM行为和体力活动的次要结局 行为参与、HF SM知识、自我效能、HF功能状态、住院和生活质量 在基线和第6、12和24周。对于我们的样本，我们将招募年龄在45岁或以上的成年人， 美国南部各州，并在过去6个月内因HF住院。我们将随机抽取200名参与者， SCDG干预组，参与者将接收跟踪体重监测的传感器， 活动，并将在移动的智能手机上播放SCDG，或将接收传感器、应用程序 跟踪活动和体重监测，以及标准化的书面HF教育材料。目标3： 将进行混合方法评估，以识别影响参与者的促进者和障碍。 参与基于传感器的干预，以实现HF SM行为依从性。对于目标4，基于每日HF SM体重监测和身体活动行为数据以及 症状、情绪、满意度和认知状态，我们将对HF SM体重进行数字表型分析， 监测和身体活动行为。该项目将产生洞察力和指导， 易于使用的数字游戏解决方案，以激励持久坚持高频SM行为和改善健康 HF患者的预后。